Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Patients with newly diagnosed, pathologically confirmed NK/T-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital

Criteria

Inclusion Criteria:

• Age≥14 years, male or female;

• Pathologically confirmed newly diagnosed NK/T cell lymphoma according to WHO classification criteria 2016;

• At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion > 1.5 cm in short axis and extranodal lesion > 1.0 cm in short axis;

• ECOG score 0~2;

• Clinical stage III~IV;

• Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9/L, PLT ≥ 75 x 10 9/L, Hb ≥ 80 g/L; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg/dL; CCr ≥ 60 mL/min; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle

• Expected survival > 6 months

• Agree to use effective contraception;

• Understand and voluntarily sign written informed consent

Exclusion Criteria:

• Prior allogeneic HCT (allo-HCT)

• Active autoimmune disease

• Primary central nervous system lymphoma;

• Patients with infection which requiring treatment. Could be re-enrollment after infection control;

• Known history of human immunodeficiency virus (HIV) infection

• Known hypersensitivity to the study drug or any of its excipients;

• Presence of other active malignancy requiring treatment that could interfere with this study;

• Patients with other conditions not suitable for enrollment as judged by the investigator.